Trial Outcomes & Findings for Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (NCT NCT05219968)

NCT ID: NCT05219968

Last Updated: 2025-05-02

Results Overview

The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 196 participants
• Primary outcome timeframe: 24 Weeks
• Results posted on: 2025-05-02

Participant Flow

Week 24 Treatment Period: 2:1 (LYR-210 to Sham) Randomization; Safety Extension Period: Sham participants received LYR-210; LYR-210 participants received LYR-210 or Sham (1:1)

Participant milestones

Measure	LYR-210 Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation	LYR-210 - LYR-210 Repeat administration of LYR-210 at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received LYR-210 in the Safety Extension. Background therapy: Saline rinse	LYR-210 - Sham Crossover from LYR-210 to sham procedure control at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received sham procedure contol in the Safety Extension. Background therapy: Saline rinse	Sham - LYR-210 Crossover from sham procedure control to LYR-210 at Week 24. Participants randomized to sham procedure contril during the Week 24 Treatment Period received LYR-210 in the Safety Extension. Background therapy: Saline rinse
Week 24 Treatment Period STARTED	130	66	0	0	0
Week 24 Treatment Period Entered Extension	84	52	0	0	0
Week 24 Treatment Period Did Not Enter Extension	40	14	0	0	0
Week 24 Treatment Period COMPLETED	103	63	0	0	0
Week 24 Treatment Period NOT COMPLETED	27	3	0	0	0
Safety Extension Period STARTED	0	0	42	42	52
Safety Extension Period COMPLETED	0	0	34	39	42
Safety Extension Period NOT COMPLETED	0	0	8	3	10

Reasons for withdrawal

Measure	LYR-210 Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation	LYR-210 - LYR-210 Repeat administration of LYR-210 at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received LYR-210 in the Safety Extension. Background therapy: Saline rinse	LYR-210 - Sham Crossover from LYR-210 to sham procedure control at Week 24. Participants randomized to LYR-210 during the Week 24 Treatment Period received sham procedure contol in the Safety Extension. Background therapy: Saline rinse	Sham - LYR-210 Crossover from sham procedure control to LYR-210 at Week 24. Participants randomized to sham procedure contril during the Week 24 Treatment Period received LYR-210 in the Safety Extension. Background therapy: Saline rinse
Week 24 Treatment Period Treatment administration failure/procedure not attempted	6	0	0	0	0
Week 24 Treatment Period Bilateral dislodgement	13	0	0	0	0
Week 24 Treatment Period Withdrawal by Subject	2	2	0	0	0
Week 24 Treatment Period Adverse Event	3	0	0	0	0
Week 24 Treatment Period Physician Decision	0	1	0	0	0
Week 24 Treatment Period Other, not specified	3	0	0	0	0
Safety Extension Period Treatment administration failure	0	0	0	1	4
Safety Extension Period Bilateral dislodgement	0	0	4	0	1
Safety Extension Period Withdrawal by Subject	0	0	2	0	4
Safety Extension Period Adverse Event	0	0	2	1	1
Safety Extension Period Lost to Follow-up	0	0	0	1	0

Baseline Characteristics

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults

Baseline characteristics by cohort

Measure	LYR-210 n=124 Participants Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control n=66 Participants Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation	Total n=190 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	107 Participants n=5 Participants	58 Participants n=7 Participants	165 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 13.65 • n=5 Participants	45 years STANDARD_DEVIATION 14.42 • n=7 Participants	48 years STANDARD_DEVIATION 14.06 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	31 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	35 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants	57 Participants n=7 Participants	168 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	111 Participants n=5 Participants	54 Participants n=7 Participants	165 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Austria	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	80 Participants n=5 Participants	42 Participants n=7 Participants	122 Participants n=5 Participants
Region of Enrollment Czechia	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Poland	28 Participants n=5 Participants	20 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment Spain	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
BMI	27.9 kg/m² STANDARD_DEVIATION 5.63 • n=5 Participants	27.4 kg/m² STANDARD_DEVIATION 4.96 • n=7 Participants	27.7 kg/m² STANDARD_DEVIATION 5.39 • n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: ITT Analysis Set Without Nasal Polyps

The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.

The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

Outcome measures

Measure	LYR-210 n=101 Participants Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control n=54 Participants Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation
Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.	-2.13 score on a scale Standard Deviation 2.172	-2.06 score on a scale Standard Deviation 2.136

SECONDARY outcome

Timeframe: Week 24

Population: ITT Analysis Set

The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.

The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

Outcome measures

Measure	LYR-210 n=124 Participants Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control n=66 Participants Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation
CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.	-2.35 score on a scale Standard Deviation 2.278	-1.83 score on a scale Standard Deviation 2.104

SECONDARY outcome

Timeframe: Week 24

Population: ITT Analysis Set

The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.

Outcome measures

Measure	LYR-210 n=124 Participants Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control n=66 Participants Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24	-19.7 score on a scale Standard Deviation 21.67	-15.7 score on a scale Standard Deviation 18.55

SECONDARY outcome

Timeframe: Week 20

Population: ITT Analysis Set

The percent opacification of the bilateral anterior and posterior ethmoids will be assessed by 3-D volumetric CT analysis at baseline and Week 20.

A negative change from Baseline indicates improvement from Baseline.

Outcome measures

Measure	LYR-210 n=124 Participants Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control n=66 Participants Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation
CFBL in the 3-D Volumetric CT Score at Week 20	-2.705 Percent ethmoid opacification Standard Deviation 10.9320	-0.279 Percent ethmoid opacification Standard Deviation 9.9706

SECONDARY outcome

Timeframe: Week 24

Population: ITT Analysis Set

This endpoint is descriptively summarized per the prespecified plan. This includes participants that used systemic corticosteroid for any reason as well as participants that were recommended/underwent sinonasal surgery.

Outcome measures

Measure	LYR-210 n=124 Participants Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control n=66 Participants Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation
Participants With Rescue Treatments for CRS Through Week 24	12 Participants	7 Participants

Adverse Events

LYR-210 up to 24 Weeks

Serious events: 4 serious events

Other events: 78 other events

Deaths: 0 deaths

Sham Procedure Control up to 24 Weeks

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

LYR-210-LYR-210 Extension

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

LYR-210-Sham Extension

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Sham-LYR-210 Extension

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	LYR-210 up to 24 Weeks n=124 participants at risk Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control up to 24 Weeks n=66 participants at risk Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation	LYR-210-LYR-210 Extension n=42 participants at risk Repeat administration of LYR-210 at Week 24	LYR-210-Sham Extension n=41 participants at risk Crossover from LYR-210 to sham procedure control at Week 24	Sham-LYR-210 Extension n=48 participants at risk Crossover from sham procedure control to LYR-210 at Week 24
Infections and infestations Colonic Abscess	0.81% 1/124 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Infections and infestations Medical Device Site Joint Infection	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	1.5% 1/66 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	3.0% 2/66 • Number of events 2 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	1.5% 1/66 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	1.5% 1/66 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.81% 1/124 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Respiratory, thoracic and mediastinal disorders Tracheal Stenosis	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	1.5% 1/66 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Cardiac disorders Coronary Artery Disease	0.81% 1/124 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Gastrointestinal disorders Haematemesis	0.81% 1/124 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Gastrointestinal disorders Nausea	0.81% 1/124 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Gastrointestinal disorders Oesophagitis	0.81% 1/124 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Nervous system disorders Loss of Consciousness	0.81% 1/124 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.1% 1/48 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.1% 1/48 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Cardiac disorders Atrial fibrillation	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.1% 1/48 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Infections and infestations Cellulitis	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/41 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Injury, poisoning and procedural complications Fall	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.1% 1/48 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.1% 1/48 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Nervous system disorders Migraine	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/41 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/42 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Psychiatric disorders Anxiety	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/42 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/41 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Renal and urinary disorders Nephrolithiasis	0.00% 0/124 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/42 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/48 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.

Other adverse events

Measure	LYR-210 up to 24 Weeks n=124 participants at risk Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation	Sham Procedure Control up to 24 Weeks n=66 participants at risk Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation	LYR-210-LYR-210 Extension n=42 participants at risk Repeat administration of LYR-210 at Week 24	LYR-210-Sham Extension n=41 participants at risk Crossover from LYR-210 to sham procedure control at Week 24	Sham-LYR-210 Extension n=48 participants at risk Crossover from sham procedure control to LYR-210 at Week 24
Respiratory, thoracic and mediastinal disorders Epistaxis	18.5% 23/124 • Number of events 29 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	10.6% 7/66 • Number of events 8 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	14.3% 6/42 • Number of events 8 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.9% 2/41 • Number of events 2 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	8.3% 4/48 • Number of events 6 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Respiratory, thoracic and mediastinal disorders Nasal Odour	18.5% 23/124 • Number of events 27 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	14.3% 6/42 • Number of events 7 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	16.7% 8/48 • Number of events 10 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Infections and infestations Upper Respiratory Tract Infection	8.1% 10/124 • Number of events 11 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	15.2% 10/66 • Number of events 13 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/42 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/41 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.1% 1/48 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Infections and infestations Chronis Sinusitis	11.3% 14/124 • Number of events 19 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.5% 3/66 • Number of events 4 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	14.3% 6/42 • Number of events 7 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	9.8% 4/41 • Number of events 5 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	8.3% 4/48 • Number of events 5 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Infections and infestations COVID-19	8.1% 10/124 • Number of events 10 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	6.1% 4/66 • Number of events 4 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	7.1% 3/42 • Number of events 3 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.9% 2/41 • Number of events 2 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.1% 1/48 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Nervous system disorders Headache	5.6% 7/124 • Number of events 9 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	1.5% 1/66 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/42 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.9% 2/41 • Number of events 2 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.2% 2/48 • Number of events 2 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Infections and infestations Nasopharyngitis	8.1% 10/124 • Number of events 11 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	9.1% 6/66 • Number of events 6 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	9.5% 4/42 • Number of events 4 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	2.4% 1/41 • Number of events 1 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.2% 2/48 • Number of events 2 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Infections and infestations Sinusitis	10.5% 13/124 • Number of events 14 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.5% 3/66 • Number of events 4 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	9.5% 4/42 • Number of events 4 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.9% 2/41 • Number of events 3 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	6.2% 3/48 • Number of events 3 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Infections and infestations Acute Sinusitis	11.3% 14/124 • Number of events 15 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/66 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	4.8% 2/42 • Number of events 2 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	0.00% 0/41 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.	8.3% 4/48 • Number of events 4 • AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52). 190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included. 131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.

Additional Information

Senior Vice President, Clinical Affairs

Lyra Therapeutics

Phone: 617-393-4600

Email: lyraclinical@lyratx.com

Results disclosure agreements

• Principal investigator is a sponsor employee Except as approved by Sponsor, single center data will not be published before multicenter data, unless \>1 year has elapsed since completion of the Study. PI may publish single center data provided that PI shall: i) provide a copy of the publication to Sponsor at least 60 days in advance of submission for publication; ii) delete Sponsor Confidential Information and make other reasonable changes; and iii) delay submission by up to 90 additional days to permit intellectual property filings.
• Publication restrictions are in place

Restriction type: OTHER